Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers (SAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00803855
First received: December 5, 2008
Last updated: May 14, 2009
Last verified: May 2009

December 5, 2008
May 14, 2009
December 2008
April 2009   (final data collection date for primary outcome measure)
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables [ Time Frame: From first to last visit ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00803855 on ClinicalTrials.gov Archive Site
  • Determine the single ascending dose pharmacokinetics of AZD1446 [ Time Frame: PK sampling taken at defined timepoints during residential period ] [ Designated as safety issue: No ]
  • Determine the single dose of AZD1446 on food interaction [ Time Frame: From first to last visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
Drug: AZD1446
oral, single dose
  • Experimental: AZD1446 Oral or placebo
    Single oral administration of AZD1446 or placebo
    Intervention: Drug: AZD1446
  • Experimental: AZD1446 Oral, with or without food
    Single oral administration of AZD1446 with or without food
    Intervention: Drug: AZD1446
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • physical healthy volunteers
  • weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

  • History of any clinically significant disease or disorder.
  • History of severe allergy/hypersensitivity reactions
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00803855
D1950C00001, EudraCT No.: 2008-006228-76
No
Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition, AstraZeneca R&D Södertälje
AstraZeneca
Not Provided
Study Director: Didier Meulien, MD, PhD, MSD AstraZeneca Södertälje
Principal Investigator: Ingemar Bylesjö, MD, PhD AstraZeneca CPU Huddinge
AstraZeneca
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP